Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRZ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
468 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121929 | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | Diacor, Inc. | 2013-01-17 | 199 | 0 |
| K910830 | INVALIFT | American Invalift Corp. | 1992-06-09 | 468 | 0 |
| K841728 | LCI MEDICAL INC AIR/PAL | Lehigh Consolidated Industries | 1984-06-05 | 41 | 0 |
| K834585 | CELLTRAK-B | R&D Systems, Inc. | 1984-05-02 | 125 | 0 |
| K840796 | TENDER LIFTING CARE | Lancer Assoc. | 1984-04-20 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda